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Regulatory Affairs Certificate Program

Comprehensive training on current regulations and their practical application

This certificate program will provide the fundamental skills you need to do your job.

Topics include but are not limited to:

  • US regulatory affairs: the IND and NDA and postmarketing
  • European regulatory requirements
  • Preparing for FDA meetings
  • Post-approval regulatory requirements
  • Regulatory requirements for product labeling & advertising
  • Electronic submissions
  • Quality assurance
  • Biosimilars
  • Biologic products
  • Drug development

Certificate Program Requirements

To successfully complete the certificate program, learners must complete 28 Core units and 16 Elective units; courses included in this program are noted below:

Course Name CE Hours Program Units
Adverse Event Reporting Requirements: IND and Post-marketing
Location - Online
None Available 3 Elective Units
Art of Writing a Clinical Overview
Location - Online
None Available 4 Elective Units
Basics of the IND
Location - Online
None Available 6 Core Units
Basics of the NDA
Location - Online
None Available 6 Core Units
Development of a Clinical Study Report
Location - Online
None Available 4 Elective Units
European Regulatory Affairs: Keeping your Finger on the Pulse of Marketing Authorizations
Location - Face-to-face
None Available 6 Core Units
Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America, and Other Emerging Markets
Location - Face-to-face
None Available 8 Elective Units
How to Prepare for a Safety Inspection
Location - Online
None Available 4 Elective Units
Interactions with the FDA during the IND/NDA Phases
Location - Online
None Available 2 Core Units
Navigating Chemistry, Manufacturing and Controls Through the Drug Development Process
Location - Face-to-face
None Available 8 Elective Units
Oversight of Clinical Monitoring: Trends and Strategies
Location - Online
None Available 3 Elective Units
Overview of Drug Development in Japan
Location - Online
None Available 6 Elective Units
Regulatory Affairs for Biologics
Location - Face-to-face
None Available 8 Core Units
Regulatory Affairs: The IND, NDA and Postmarketing
Location - Face-to-face
None Available 16 Core Units
Regulatory Aspects of Prescription Drug/Biologics Advertising and Promotional Labeling
Location - Online
None Available 2 Core Units